Several studies have shown that Continuous Subcutaneous Insulin Infusion together with Continuous Glucose Monitoring improves glycemic control in type 1 diabetes when compared to more traditional approaches; however, in available trials the basal insulin used in multi-injection therapy is typically glargine, which is associated with a higher hypoglycemic risk than degludec. This study will assess the efficacy and safety of Continuous Subcutaneous Insulin infusion (CSII) combined with Continuous Glucose Monitoring (CGM), as compared to Multiple Daily Injections (MDI) of insulin analogues, using degludec as basal insulin, associated with traditional self-monitoring of capillary blood glucose (SMBG) in patients with type 1 diabetes. A crossover design was chosen in order to minimize study sample improving statistical power.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Animas Vibe Platinum insulin pump and Dexcom G4 CGM
Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin
Diabetologia AOU Careggi
Florence, Italy
HbA1c
Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase)
Time frame: 4 months
Severe Hypoglycemia
Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase
Time frame: 4 months
Local Reactions
Number of participants with local reactions at infusion/glucose monitoring site
Time frame: 4 months
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